Manufacturer's investigation conclusion: the reported event of the controller not showing any parameters and alarming with a communication fault was confirmed via visual analysis and testing of the controller and via analysis of the downloaded log file.The heartmate 3 system controller (serial number (b)(6) ) was returned and evaluated at abbott.During the evaluation, the controller was connected to a mock circulatory loop and a log file was downloaded.The downloaded log file from the returned system controller contained data spanning approximately 1 day (04jul2022 ¿ 05jul2022 per the timestamps).The log file captured intermittent controller internal fault alarms active throughout the log file due to a timebase fault.The alarm would resolve intermittently and then reoccur intermittently.The alarms did not resolve by the end of the log file.While the timebase faults were active, it appears as if the fixed and low speed limits were changed as there was a loss of lvad communication.The flow also appeared to drop as a result of the loss of communication.Additionally, the controller was functionally tested and passed all steps without issue; however, while the controller was operating on a mock circulatory loop for an extended period of time, the controller had a communication fault active.While the communication fault was active, the controller was not communicating with the system monitor, confirming the reported event.Circuit analysis revealed that the communication fault and communication issue with the system monitor was intermittent.The circuit analysis of the controller¿s circuitry did not reveal any issues with the components, and it appeared that the circuit was continuously resetting the microcontroller.A possible issue with the microcontroller was suspected and the pcb was forwarded to the vendor (plexus manufacturing) for further evaluation along with another pcb which was demonstrating similar behavior.A manufacturing task was initiated to investigate further.The root cause of the hm3 controller issue is due to the microprocessor corrosion issue on the control main pcba, but it is inconclusive how the control main pcba had an issue post-manufacturing and testing at abbott mcs.An external corrective action report (ecar) was created to address the issue.The manufacturer was notified of the complaint through the ecar, and the supplier will address this issue and provide a response with the corrective action.The root cause of the reported event was determined to be due corrosion within the microcontroller; however, the root cause of the corrosion could not be conclusively determined through this analysis.The device history records were reviewed, and the records revealed the heartmate 3 system controller (serial # (b)(6) ) was manufactured in accordance with manufacturing and quality assurance specifications.The system controller (serial # (b)(6) ) was shipped from abbott on 04jan2022.Heartmate 3 patient handbook section 5, entitled ¿alarms and troubleshooting¿, and heartmate 3 instructions for use section 7, entitled ¿alarms and troubleshooting¿, cover all alarms (visual and audible), including the controller fault alarm conditions, and the actions to take if the alarms cannot be resolved.Heartmate 3 patient handbook section 6, entitled "caring for the equipment", describes how to care for and clean all equipment, including the system controller.Heartmate 3 patient handbook cautions users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.
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